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Clinical Trials/EUCTR2006-003415-46-DE
EUCTR2006-003415-46-DE
Active, not recruiting
Not Applicable

A phase III trial investigating the efficacy and safety of Grazax in children aged 5-16 years with grass pollen induced rhinoconjunctivitis with or without asthma

ALK-Abello, Group Clinical Development0 sitesSeptember 25, 2006
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ConditionsIgE Mediated allergy (hay fever, rhinoconjunctivitis) to grass pollen (Timothy grass, Phleum pratense) with or without asthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
IgE Mediated allergy (hay fever, rhinoconjunctivitis) to grass pollen (Timothy grass, Phleum pratense) with or without asthma
Sponsor
ALK-Abello, Group Clinical Development
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 25, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ALK-Abello, Group Clinical Development

Eligibility Criteria

Inclusion Criteria

  • •To investigate the efficacy and safety of Grazax based on the following information:
  • •?Rhinoconjunctivitis symptom and medication scores in the peak grass pollen season
  • •?Asthma symptom and medication score in the grass pollen season
  • •?Asthma symptom and medication score in the peak grass pollen season
  • •?Pharmacoeconomic data in the grass pollen season
  • •?Safety Assessments at screening and End of treatment
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • •Exclusion criteria
  • •1\.Current food allergies with oral allergy syndrome
  • •2\.A clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication due to another allergen during – or potentially overlapping \- the grass pollen season.
  • •3\.A clinical history of perennial allergic rhinitis and/or asthma having received regular medication due to an allergen to which the subject is regularly exposed
  • •4\.A clinical history of chronic sinusitis during the last 2 years
  • •5\.A clinical history of severe asthma (Step 4, according to GINA definition)
  • •6\.Any clinical relevant chronic disease
  • •7\.Current severe atopic dermatitis
  • •8\.Use of an investigational drug within 30 days prior to screening
  • •9\.Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years

Outcomes

Primary Outcomes

Not specified

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